MAUDE Adverse Event Report: BECTON DICKINSON HSCT KOR IV SET TPE 5UM AP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 388065

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  malfunction  

Event Description

The customer connected the tube to the piggy bag for iv injection of the drug, but the amount was not injected due to stagnant drug flow due to tube kinking.23-jan-2024 ¿ received an email replies from complainant for additional information.Please return the affected product(s) (with its original packaging if possible) for investigation? ¿ if it is not possible to return the affected product, please provide detailed photographs of the product(s) and the damaged area(s)? i will return the sample as soon as possible.¿ please confirm the infusion setup? i don¿t know the setup ¿ please confirm what substance was being infused during the time of the event? 0.9% normal saline.¿ please confirm when the fault was identified during priming or during infusion? if during infusion, how long into the infusion? during infusion and within 30 min.¿ please confirm the exact location of the reported fault within the set? from the clamp to the filter.¿ please confirm if the kinked occurred in packaging or during use? during use.Manikandanr.

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.

Manufacturer Narrative

Correction: this product is exempt from reporting and the mdr is no longer needed.

Event Description

No additional information.

• Brand Name: HSCT KOR IV SET TPE 5UM AP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18616133
• MDR Text Key: 334882372
• Report Number: 9616066-2024-00149
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388065
• Device Lot Number: 20210830
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1